Rocket AF Controversy

Rocket AF Controversy
Feb 15, 2016 11:37am

It appears the often-criticized Rocket AF clinical trial, the results of which the FDA used to approve rivaroxaban (Xarelto), may have been flawed by the use of the Alere INRatio2 PT/INR point of care device in its Coumadin arm, recalled by the FDA in January of 2015. Read more in Medscape.

1 Comment
By Dr Emmanuel Favaloro
Feb 16, 2016 4:06am
John Mandrola wrote a very strong case for not yet abandoning rivaroxaban in his Medscape piece, whilst also imploring the manufacturer to open the data to outside scrutiny. It is always concerning when such data is 'over-protected' from independent scrutiny. Many of us saw this value of 55% 'in therapeutic range' for warfarin as being a little low, particularly for a clinical trial. I guess this also opens up some additional general concerns about POC testing for INR? Should your readers have an interest in this area, I will make a plug for recent papers in STH on this...
Kitchen DP, Jennings I, Kitchen S, Woods TA, Walker ID. Bridging the gap between point-of-care testing and laboratory testing in hemostasis. Semin Thromb Hemost. 2015;41:272–8.
and...
Bonar R, Mohammed S, Favaloro EJ. International normalized ratio monitoring of vitamin K antagonist therapy: comparative performance of point-of-care and laboratory-derived testing. Semin Thromb Hemost. 2015;41:279–86.

Leave A Comment

You must be logged in to Comment - Sign In